MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a broken 3cg stylet was confirmed, but the exact cause could not be determined.One dual-lumen (d/l) powerpicc catheter was returned for investigation with a 3cg stylet.The d/l tubing had been cut 7.2¿ from the distal end of the molded wing and the distal segment of the catheter was not returned for investigation.The t-lock extension set was received attached to the red connector and the stylet had been pulled through the catheter, which caused the yellow tab to sit adjacent to the septum on the t-lock extension set.The distal end of the stylet wire extended 17.3¿ from the distal tip of the catheter.A microscopic examination revealed that the epoxy tip, five magnets, and the distal segment of polyimide tubing were missing from the stylet.Sixteen magnets were observed in the proximal segment of polyimide tubing.Eight kinks were observed in the returned segment of polyimide tubing, which was 2.34¿ in length.The wall thickness of the polyimide tubing was within specification.Kinking of the polyimide tubing and advancement against resistance may have been potential contributing factors in the observed damage; however, the exact cause of the reported event could not be determined.The ifu for the 3cg stylet states, ¿ensure that the stylet tip does not extend beyond the trimmed end of the catheter.Extension of the stylet tip beyond the catheter end, combined with kinking and excessive forces, may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury.¿ a lot history review (lhr) of reeu3524 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "met axillary obstruction, stopped procedure, withdrew 3cg stylet but could not pull out, doctor assisted and successfully pulled out guidewire, and it was not intact".
Event or Problem Description
It was reported "met axillary obstruction, stopped procedure, withdrew 3cg stylet but could not pull out, doctor assisted and successfully pulled out guidewire, and it was not intact".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a broken 3cg stylet was confirmed, but the exact cause could not be determined.One dual-lumen (d/l) powerpicc catheter was returned for investigation with a 3cg stylet.The d/l tubing had been cut 7.2¿ from the distal end of the molded wing and the distal segment of the catheter was not returned for investigation.The t-lock extension set was received attached to the red connector and the stylet had been pulled through the catheter, which caused the yellow tab to sit adjacent to the septum on the t-lock extension set.The distal end of the stylet wire extended 17.3¿ from the distal tip of the catheter.A microscopic examination revealed that the epoxy tip, five magnets, and the distal segment of polyimide tubing were missing from the stylet.Sixteen magnets were observed in the proximal segment of polyimide tubing.Eight kinks were observed in the returned segment of polyimide tubing, which was 2.34¿ in length.The wall thickness of the polyimide tubing was within specification.Kinking of the polyimide tubing and advancement against resistance may have been potential contributing factors in the observed damage; however, the exact cause of the reported event could not be determined.The ifu for the 3cg stylet states, ¿ensure that the stylet tip does not extend beyond the trimmed end of the catheter.Extension of the stylet tip beyond the catheter end, combined with kinking and excessive forces, may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury.¿ h3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11167407
• Report Number: 3006260740-2020-21303
• Device Sequence Number: 11606072
• Product Code: LJS
• UDI-Device Identifier: 00801741034565
• UDI-Public: (01)00801741034565
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1275108F
• Device Lot Number: REEU3524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other